臨床研究等提出・公開システム

Date of registration	May. 25, 2020
Last modified on	Jan. 18, 2022
Trial ID	jRCT2080225203

Scientific Title	Dose-finding study of KP-607 in patients with onychomycosis (PhaseII)
Public Title	Dose-finding study of KP-607 in patients with onychomycosis (PhaseII)

Completion Date or Terminated date	Dec. 10, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	KAKEN PHARMACEUTICAL CO., LTD.
	Address
	Phone Number	+81-3-5977-5111
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	KAKEN PHARMACEUTICAL CO., LTD.
	Address
	Phone Number	+81-3-5977-5065
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		June. 22, 2020
Target Sample Size		81
Study Type		Interventional
Study Design	Study Design	randomized, vehicle controlled, double-blind, parallel group, multicenter
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	Japanese subjects The subjects diagnosed with onychomycosis Presence of 20-50% of the area of the target nail being clinically affected (as determined by the Investigator)
	Exclusion Criteria	Patients who have received corticosteroids,immunosuppressants, or antifungals drugs within a certain period of time before screening period
	Minimum Age	20age old over
	Maximum Age	69age old under
	Gender	Both
Health Condition or Problem Studied		Onychomycosis
Intervention(s)		investigational material(s) Generic name etc : 10% KP-607, 5% KP-607 INN of investigational material : - Therapeutic category code : 265 Anti-dermoinfectives Dosage and Administration for Investigational material : Apply 10% KP-607 or 5% KP-607 to all of the affected toenail(s) once daily. control material(s) Generic name etc : 0% KP-607 INN of investigational material : - Therapeutic category code : 265 Anti-dermoinfectives Dosage and Administration for Investigational material : Apply 0% KP-607 to all of the affected toenail(s) once daily.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy Safety, Efficacy
Secondary Outcome		pharmacokinetics KP-607 and its metabolites concentrations when applied repeatedly to toenails in patients with onychomycosis

Primary Sponsor	KAKEN PHARMACEUTICAL CO., LTD.
Secondary Sponsor	-

Name of Funding Organization	KAKEN PHARMACEUTICAL CO., LTD.
Name of Research Funding	-

Name of IRB	Shinanozaka Clinic, Institutional Review Board
Address of IRB	20 Samon-cho, Shinjuku-ku, Tokyo, 160-0017, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	May. 27, 2020

Secondary ID No.	JapicCTI-205299
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Jan. 18, 2022	(this page)	Changes
3	Oct. 20, 2020	Detail	Changes
2	Sept. 14, 2020	Detail	Changes
1	May. 27, 2020	Detail

List of change history